PITAVASTATIN SANDOZ 1 mg FILM-COATED TABLETS

2. What you need to know before you take Pitavastatina Sandoz

Do not take Pitavastatina Sandoz:

• if you are allergic to pitavastatina or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you are a woman who can become pregnant and are not using a reliable contraceptive method (see ‘Pregnancy, breast-feeding and fertility’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplants.
• if you have repeated or unexplained muscle pain.
• if you have any doubts, consult your doctor or pharmacist before taking pitavastatina.

Warnings and precautions

Consult your doctor or pharmacist before taking Pitavastatina Sandoz.

• if you have severe respiratory problems (serious breathing problems).
• if you have ever had kidney problems.
• if you have ever had liver problems. ‘Statins’ can affect the liver in some people. Your doctor will usually do blood tests (to see how your liver is working) before and during treatment with pitavastatina.
• if you have ever had thyroid problems.
• if you or a family member have a history of muscle problems.
• if you have previously had muscle problems when taking other medicines to lower cholesterol (e.g. statins or fibrates).
• if you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make the disease worse or cause myasthenia to appear (see section 4),
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and pitavastatina can cause serious muscle problems (rhabdomyolysis).

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking pitavastatina. Also, inform your doctor or pharmacist if you experience constant muscle weakness. You may need tests and additional medication to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Children and adolescents

Pitavastatina should not be given to children under 6 years of age.

Before taking pitavastatina, adolescent girls should receive guidance and counseling on contraceptives.

Other medicines and Pitavastatina Sandoz

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription or herbal products. Some medicines can interfere with others. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines called ‘fibrates’, such as gemfibrozil and fenofibrate,
• erythromycin or rifampicin, antibiotics used for infections,
• warfarin or any other medicine used to thin the blood,
• HIV medicines called ‘protease inhibitors’ (e.g. ritonavir, lopinavir, darunavir, atazanavir) and non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz),
• niacin (Vitamin B3),

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking pitavastatina.

Taking Pitavastatina Sandoz with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breast-feeding and fertility

Do not take pitavastatina if you are pregnant or breast-feeding. If you want to become pregnant, inform your doctor before taking pitavastatina. If you are a woman who can become pregnant, you must use a reliable contraceptive method while taking pitavastatina. If you become pregnant while taking pitavastatina, stop taking pitavastatina and consult your doctor immediately.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pitavastatina is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatina, do not drive or use machines or tools.

Pitavastatina Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Pitavastatina Sandoz

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Taking this medicine

Swallow the tablet whole with water, with or without food. You can take it at any time of day. However, try to take the tablet at the same time each day.

How much to take

• The usual starting dose is 1 mg once a day. After a few weeks, your doctor may decide to increase your dose. The maximum dose in adults and children over 10 years is 4 mg a day.
• If you have liver problems, you should not take more than 2 mg a day.

Use in children and adolescents

• The maximum dose in children under 10 years is 2 mg a day.
• If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.
• Pitavastatina is not recommended for use in children under 6 years of age.

Other things you need to know while taking Pitavastatina Sandoz

• If you go to the hospital or receive treatment for another problem, tell the medical staff that you are taking pitavastatina.
• Your doctor may do tests to check your cholesterol levels regularly.
• Do not stop taking pitavastatina without talking to your doctor first. Your cholesterol levels may rise.

If you take more Pitavastatina Sandoz than you should

If you take more pitavastatina than you should, tell your doctor or go to the hospital immediately. Take the medicine pack with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pitavastatina Sandoz

Do not worry, take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and see a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• allergic reaction: some signs include difficulty breathing, swelling of the face, lips, tongue, or throat, problems swallowing (angioedema) (frequency cannot be estimated from the available data), intense itching of the skin (with hives)
• unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or if your urine is brown-colored. In rare cases (less than 1 in 1,000), pitavastatina can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems
• respiratory problems, including persistent cough and/or difficulty breathing or fever
• liver problems that can cause yellowing of the skin and eyes (jaundice)
• pancreatitis (severe abdominal and back pain)
• rash, joint disorders, and effects on blood cells (lupus-like syndrome) (frequency cannot be estimated from the available data)
• breast enlargement in men (gynecomastia) (may affect up to 1 in 1,000 people).

Other side effects include:

Common (affect less than 1 in 10 people)

• joint pain, muscle pain
• constipation, diarrhea, indigestion, nausea
• headache.

Uncommon (affect less than 1 in 100 people)

• muscle spasms
• weakness, tiredness, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• pallor and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face.

Rare (affect less than 1 in 1,000 people)

• redness of the skin, rash, and itching of the skin
• worsening of vision
• tongue pain
• unpleasant sensation or discomfort in the stomach
• breast enlargement in men (gynecomastia).

Side effects of unknown frequency

• constant muscle weakness
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells),
• severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing),
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects

• memory loss
• sexual dysfunction
• depression
• diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatina Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Pitavastatina Sandoz

• The active substance is pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 1 mg of pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 2 mg of pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 4 mg of pitavastatina.

• The other ingredients are:

Core of the tablet:lactose monohydrate, hypromellose 5 cP, hydroxypropylcellulose, and magnesium stearate.

Coating:

1 mg tablets:hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172).

2 mg tablets:hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

4 mg tablets: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

Appearance and packaging of the product

1 mg film-coated tablets: film-coated tablets, round, biconvex, yellow-brown in color, and engraved with the mark “1” on one side. Tablet size: diameter approximately 6 mm.

2 mg film-coated tablets: film-coated tablets, round, biconvex, orange-brown in color, and engraved with the mark “2” on one side. Tablet size: diameter approximately 7 mm.

4 mg film-coated tablets: film-coated tablets, round, biconvex, red-brown in color, and engraved with the mark “4” on one side. Tablet size: diameter approximately 9 mm.

The film-coated tablets are packaged in PVC/PVDC/Alu blisters, which are packaged in a cardboard box.

Package sizes:

Blister: 7, 28, 30, 90, and 100 film-coated tablets.

Blister (unit dose): 7 x 1, 28 x 1, 30 x 1, 90 x 1, or 100 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal Pitavastatina Sandoz

Date of last revision of this leaflet: April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).